Pregabalin Impurity PD0310806 CAS 501666-22-4
| CAS No. | 501666-22-4 |
| Molecular Formula | C14H25NO6 |
| Molecular Weight | 303.35 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Pregabalin Impurity PD0310806 (CAS 501666-22-4) is a certified pharmaceutical impurity reference standard with the molecular formula C14H25NO6 and a molecular weight of 303.35 g/mol.
The molecular framework of Pregabalin Impurity PD0310806 (C14H25NO6) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
Physical & Chemical Properties
| Molecular Formula | C14H25NO6 |
| Molecular Weight | 303.35 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1984 |
| Nitrogen Atoms | 1 |
Related Pregabalin Standards
- Pregabalin Impurity PD0310887 (CAS CATO-C4X-131210)
- Pregabalin Impurity PD 0224377 (CAS CATO-C4X-13128)
- Pregabalin Impurity 15 (CAS 1083246-65-4)
- Pregabalin Impurity 90 (CAS 1486961-58-3)
- Pregabalin impurity 97 (CAS 2361911-35-3)
- Pregabalin Impurity 99 (CAS 949890-75-9)
- Pregabalin Impurity 138 (CAS 930585-94-7)
- Pregabalin Impurity 34 (CAS 930280-44-7)
Recommended Standards
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